The National Comprehensive Cancer Network released updated bladder cancer guidelines that include Natera’s Signatera minimal residual disease (MRD) test for muscle-invasive disease after cystectomy. The guidance recommends Genentech’s Tecentriq (atezolizumab) for patients who are MRD-positive within one year, based on results from the IMvigor011 trial. The NCCN update also provides a broader recommendation to consider tumor-informed MRD testing to support risk stratification and adjuvant immunotherapy decisions. The guideline specifies that MRD testing should be FDA-approved, personalized, tumor-informed, multiplex, and use PCR-based next-generation sequencing of circulating tumor DNA. In IMvigor011, among ctDNA-positive patients with no radiographic evidence of disease, Tecentriq nearly doubled disease-free survival versus placebo (9.9 months vs 4.8 months) and improved overall survival (32.8 months vs 21.1 months). The NCCN inclusion supports Signatera specifically, reflecting its status as an FDA-approved companion diagnostic for this use case. Commercially, analysts noted that NCCN guideline coverage can drive payer adoption, an important step for expanding MRD assay penetration in post-surgery oncology care pathways.
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